The Therapeutic Goods Administration (TGA) has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.
This is the first application received by the TGA to transition a provisionally-approved COVID-19 vaccine to full registration. However, a number of COVID-19 vaccines, including SPIKEVAX already have the equivalent of full registration (market authorisation) in major overseas countries.
Currently in Australia this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 months and older, and as a booster dose for individuals aged 12 years and older.
As part of the provisional approval, sponsors are required to continue to submit longer-term evidence of safety and efficacy to the TGA. Data from these ongoing trials can support a sponsor’s application to transition their COVID-19 vaccine to full registration status. The TGA will undertake a rigorous assessment of the safety, efficacy and quality of this vaccine for use in individuals 6 years of age and older.
Further information on the transition from provisional to full registration is available at: Provisional registration extension and transition to full registration.
Information about Australia’s vaccine rollout can be found on the Department of Health and Aged Care’s webpage.
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